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1.
Annu Rev Med ; 72: 199-213, 2021 01 27.
Artigo em Inglês | MEDLINE | ID: mdl-33502898

RESUMO

Ulcerative colitis (UC) is a relapsing and remitting inflammatory disease of the colon with a variable course. Despite advances in treatment, only approximately 40% of patients achieve clinical remission at the end of a year, prompting the exploration of new treatment modalities. This review explores novel therapeutic approaches to UC, including promising drugs in various stages of development, efforts to maximize the efficacy of currently available treatment options, and non-medication-based modalities. Treatment approaches which show promise in impacting the future of UC management are highlighted.


Assuntos
Antiulcerosos/uso terapêutico , Colite Ulcerativa/terapia , Transplante de Microbiota Fecal/métodos , Oxigenoterapia Hiperbárica/métodos , Fatores Imunológicos/uso terapêutico , Inibidores de Janus Quinases/uso terapêutico , Moduladores do Receptor de Esfingosina 1 Fosfato/uso terapêutico , Humanos
2.
J Clin Gastroenterol ; 57(9): 908-912, 2023 10 01.
Artigo em Inglês | MEDLINE | ID: mdl-36149668

RESUMO

BACKGROUND: Inflammatory bowel disease (IBD) patients are known to benefit from care delivered in a specialized, interdisciplinary setting. We aimed to evaluate the impact of this model on health outcomes, quality metrics, and health care resource utilization (HRU) in IBD patients insured with Medicaid. MATERIALS AND METHODS: In July 2017, IBD patients at our tertiary hospital were transitioned from a fellows' general gastroenterology (GI) clinic to a fellows' interdisciplinary IBD clinic. IBD patients were included if they were insured with Medicaid, had at least 1 visit in the general GI clinic between July 1, 2016 and June 30, 2017, and at least 1 visit between July 1, 2017 and June 30, 2018 in the IBD clinic. Characteristics related to patients' IBD course, overall health care maintenance, and HRU were compared. RESULTS: A total of 170 patients (51% male, mean age 39 y) were included. After the transition to the IBD clinic, use of corticosteroids (37% vs. 25%; P =0.004) and combination therapy were significantly lower (55% vs. 38%; P =0.0004), although use of high-dose biologics numerically increased (58.5% vs. 67%; P =0.05). Posttransition, patients showed significantly lower levels of mean C-reactive protein ( P =0.04). After the transition, patients attended significantly fewer outpatient GI visits ( P =0.0008) but were more often seen by other health care specialists ( P =0.0003), and experienced a numeric decrease in HRU with fewer emergency department visits, hospitalizations, and surgeries. CONCLUSIONS: Care in an interdisciplinary, IBD specialty setting is associated with significantly decreased corticosteroid use, decreased C-reactive protein levels, and improved access to ancillary services in Medicaid patients.


Assuntos
Doenças Inflamatórias Intestinais , Medicaid , Estados Unidos , Humanos , Masculino , Adulto , Feminino , Proteína C-Reativa , Doenças Inflamatórias Intestinais/terapia , Aceitação pelo Paciente de Cuidados de Saúde , Atenção à Saúde , Hospitalização
3.
Am J Ind Med ; 65(2): 117-131, 2022 02.
Artigo em Inglês | MEDLINE | ID: mdl-34825393

RESUMO

BACKGROUND: The World Trade Center (WTC) general responder cohort (GRC) was exposed to environmental toxins possibly associated with increased risk of developing autoimmune conditions. OBJECTIVES: Two study designs were used to assess incidence and risks of autoimmune conditions in the GRC. METHODS: Three clinically trained professionals established the status of possible GRC cases of autoimmune disorders adhering to diagnostic criteria, supplemented, as needed, by specialists' review of consenting responders' medical records. Nested case-control analyses using conditional logistic regression estimated the risk associated with high WTC exposure (being in the 9/11/2001 dust cloud or ≥median days' response worked) compared with low WTC exposure (all other GRC members'). Four controls were matched to each case on age at case diagnosis (±2 years), sex, race/ethnicity, and year of program enrollment. Sex-specific and sensitivity analyses were performed. GRC age- and sex-adjusted standardized incidence ratios (SIRs) were compared with the Rochester Epidemiology Project (REP). Complete REP inpatient and outpatient medical records were reviewed by specialists. Conditions meeting standardized criteria on ≥2 visits were classified as REP confirmed cases. RESULTS: Six hundred and twenty-eight responders were diagnosed with autoimmune conditions between 2002 and 2017. In the nested case-control analyses, high WTC exposure was not associated with autoimmune domains and conditions (rheumatologic domain odds ratio [OR] = 1.03, 95% confidence interval [CI] = 0.77, 1.37; rheumatoid arthritis OR = 1.12, 95% CI = 0.70, 1.77). GRC members had lower SIR than REP. Women's risks were generally greater than men's. CONCLUSIONS: The study found no statistically significant increased risk of autoimmune conditions with WTC exposures.


Assuntos
Doenças Autoimunes , Socorristas , Exposição Ocupacional , Ataques Terroristas de 11 de Setembro , Doenças Autoimunes/epidemiologia , Estudos de Casos e Controles , Feminino , Humanos , Incidência , Masculino , Cidade de Nova Iorque , Exposição Ocupacional/efeitos adversos
4.
Clin Gastroenterol Hepatol ; 19(10): 2207-2209.e3, 2021 10.
Artigo em Inglês | MEDLINE | ID: mdl-33068786

RESUMO

The safety and efficacy of tofacitinib in Crohn's disease (CD) has been studied in 2 phase II trials in patients with moderate-to-severe CD with no new safety signals observed, but no significant difference from placebo in the primary efficacy endpoint of clinical response.1-3 However, post hoc analyses and smaller studies have observed clinical and biologic response to tofacitinib in patients with CD.2,4,5 There is a paucity of real-world effectiveness and safety data for tofacitinib in non-Food and Drug Administration label usage in patients with CD and patients with inflammatory bowel disease-unclassified (IBD-U).


Assuntos
Doença de Crohn , Doenças Inflamatórias Intestinais , Doença de Crohn/tratamento farmacológico , Humanos , Doenças Inflamatórias Intestinais/tratamento farmacológico , Piperidinas , Pirimidinas/efeitos adversos , Pirróis/efeitos adversos
5.
Clin Gastroenterol Hepatol ; 19(8): 1592-1601.e3, 2021 08.
Artigo em Inglês | MEDLINE | ID: mdl-32629130

RESUMO

BACKGROUND & AIMS: Adverse events (AEs) including reactivation of herpes zoster (HZ) and venous thromboembolism (VTE) have been reported from clinical trials of tofacitinib in ulcerative colitis (UC). We investigated the incidence rates of AEs in a real-world study of UC patients given tofacitinib. METHODS: We collected data from 260 patients with UC in the Tofacitinib Real-world Outcomes in Patients with ulceratIve colitis and Crohn's disease consortium study, performed at 6 medical centers in the United States. Patients were followed up for a median of 6 months (interquartile range, 2.7-11.5 mo). AEs were captured using a standardized data collection instrument before study initiation and at weeks 8, 16, 26, 39, and 52. Serious AEs were defined as life-threatening or resulting in a hospitalization, disability, or discontinuation of therapy. Logistic regression was performed to examine risk factors for AEs. RESULTS: AEs occurred in 41 patients (15.7%); most were infections (N = 13; 5.0%). The incidence rate of any AE was 27.2 (95% CI, 24.4-30.7 per 100 patient-years of follow-up evaluation). Fifteen were serious AEs (36.6% of AEs), and tofacitinib was discontinued for 12 patients (4.6% of cohort). The incidence rates of serious AEs was 10.0 (95% CI, 8.9-11.2 per 100 patient-years of follow-up evaluation). Five patients developed HZ infection and 2 developed VTE (all receiving 10 mg tofacitinib, twice per day). CONCLUSIONS: Real-world safety signals for tofacitinib are similar to those for clinical trials, with AEs reported from almost 16% of patients. HZ infection and VTE occurred in patients receiving 10 mg tofacitinib twice per day. These results support dose de-escalation after induction therapy, to reduce the risk of AEs.


Assuntos
Colite Ulcerativa , Colite Ulcerativa/tratamento farmacológico , Humanos , Piperidinas/efeitos adversos , Pirimidinas/efeitos adversos , Pirróis/efeitos adversos
6.
Dig Dis Sci ; 66(6): 1836-1844, 2021 06.
Artigo em Inglês | MEDLINE | ID: mdl-32705439

RESUMO

BACKGROUND: Wearable devices are designed to capture health-related and physiological data. They may be able to improve inflammatory bowel disease management and address evolving research needs. Little is known about patient perceptions for their use in the study and management of inflammatory bowel disease. AIMS: The aim of this survey study is to understand patient preferences and interest in wearable technology. METHODS: Consecutive adult patients who self-reported having inflammatory bowel disease were approached at the Susan and Leonard Feinstein Inflammatory Bowel Disease Center at the Mount Sinai Hospital to complete a 28-question survey. Reponses were analyzed with descriptive statistics. The Pearson Chi-square test and Fischer's exact test were used to determine the association between demographic and disease-related features and survey responses. RESULTS: Four hundred subjects completed the survey. 42.7% of subjects reported prior or current use of wearable devices. 89.0% of subjects believed that wearable devices can provide important information about their health, while 93.8% reported that they would use a wearable device if it could help their doctor manage their IBD. Subjects identified wrist-worn devices as the preferred device type and a willingness to wear these devices at least daily. CONCLUSIONS: Patients with inflammatory bowel disease believe that wearable devices can provide important information about their health and report a willingness to wear them frequently in research studies and as part the routine management of inflammatory bowel disease.


Assuntos
Gerenciamento Clínico , Doenças Inflamatórias Intestinais/diagnóstico , Doenças Inflamatórias Intestinais/psicologia , Aceitação pelo Paciente de Cuidados de Saúde/psicologia , Inquéritos e Questionários , Dispositivos Eletrônicos Vestíveis/psicologia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Estudos Transversais , Feminino , Humanos , Doenças Inflamatórias Intestinais/terapia , Masculino , Pessoa de Meia-Idade , Dispositivos Eletrônicos Vestíveis/tendências , Adulto Jovem
7.
J Med Internet Res ; 23(9): e31295, 2021 09 13.
Artigo em Inglês | MEDLINE | ID: mdl-34379602

RESUMO

BACKGROUND: The COVID-19 pandemic has resulted in a high degree of psychological distress among health care workers (HCWs). There is a need to characterize which HCWs are at an increased risk of developing psychological effects from the pandemic. Given the differences in the response of individuals to stress, an analysis of both the perceived and physiological consequences of stressors can provide a comprehensive evaluation of its impact. OBJECTIVE: This study aimed to determine characteristics associated with longitudinal perceived stress in HCWs and to assess whether changes in heart rate variability (HRV), a marker of autonomic nervous system function, are associated with features protective against longitudinal stress. METHODS: HCWs across 7 hospitals in New York City, NY, were prospectively followed in an ongoing observational digital study using the custom Warrior Watch Study app. Participants wore an Apple Watch for the duration of the study to measure HRV throughout the follow-up period. Surveys measuring perceived stress, resilience, emotional support, quality of life, and optimism were collected at baseline and longitudinally. RESULTS: A total of 361 participants (mean age 36.8, SD 10.1 years; female: n=246, 69.3%) were enrolled. Multivariate analysis found New York City's COVID-19 case count to be associated with increased longitudinal stress (P=.008). Baseline emotional support, quality of life, and resilience were associated with decreased longitudinal stress (P<.001). A significant reduction in stress during the 4-week period after COVID-19 diagnosis was observed in the highest tertial of emotional support (P=.03) and resilience (P=.006). Participants in the highest tertial of baseline emotional support and resilience had a significantly different circadian pattern of longitudinally collected HRV compared to subjects in the low or medium tertial. CONCLUSIONS: High resilience, emotional support, and quality of life place HCWs at reduced risk of longitudinal perceived stress and have a distinct physiological stress profile. Our findings support the use of these characteristics to identify HCWs at risk of the psychological and physiological stress effects of the pandemic.


Assuntos
COVID-19 , Pandemias , Adulto , Teste para COVID-19 , Feminino , Pessoal de Saúde , Humanos , Cidade de Nova Iorque , Qualidade de Vida , SARS-CoV-2 , Estresse Fisiológico , Estresse Psicológico/epidemiologia
8.
J Med Internet Res ; 23(2): e26107, 2021 02 22.
Artigo em Inglês | MEDLINE | ID: mdl-33529156

RESUMO

BACKGROUND: Changes in autonomic nervous system function, characterized by heart rate variability (HRV), have been associated with infection and observed prior to its clinical identification. OBJECTIVE: We performed an evaluation of HRV collected by a wearable device to identify and predict COVID-19 and its related symptoms. METHODS: Health care workers in the Mount Sinai Health System were prospectively followed in an ongoing observational study using the custom Warrior Watch Study app, which was downloaded to their smartphones. Participants wore an Apple Watch for the duration of the study, measuring HRV throughout the follow-up period. Surveys assessing infection and symptom-related questions were obtained daily. RESULTS: Using a mixed-effect cosinor model, the mean amplitude of the circadian pattern of the standard deviation of the interbeat interval of normal sinus beats (SDNN), an HRV metric, differed between subjects with and without COVID-19 (P=.006). The mean amplitude of this circadian pattern differed between individuals during the 7 days before and the 7 days after a COVID-19 diagnosis compared to this metric during uninfected time periods (P=.01). Significant changes in the mean and amplitude of the circadian pattern of the SDNN was observed between the first day of reporting a COVID-19-related symptom compared to all other symptom-free days (P=.01). CONCLUSIONS: Longitudinally collected HRV metrics from a commonly worn commercial wearable device (Apple Watch) can predict the diagnosis of COVID-19 and identify COVID-19-related symptoms. Prior to the diagnosis of COVID-19 by nasal swab polymerase chain reaction testing, significant changes in HRV were observed, demonstrating the predictive ability of this metric to identify COVID-19 infection.


Assuntos
Teste para COVID-19/métodos , COVID-19/diagnóstico , COVID-19/fisiopatologia , Frequência Cardíaca/fisiologia , Dispositivos Eletrônicos Vestíveis , Adulto , COVID-19/virologia , Ritmo Circadiano/fisiologia , Feminino , Pessoal de Saúde , Humanos , Masculino , SARS-CoV-2/genética , SARS-CoV-2/isolamento & purificação
9.
Clin Gastroenterol Hepatol ; 18(6): 1336-1345, 2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-31887444

RESUMO

De-escalation of immunomodulators and biologic agents in inflammatory bowel disease is frequently discussed with patients and must weigh the risk of continued medical therapy with the risk of disease recurrence. Risk factors for disease flare after withdrawal of inflammatory bowel disease medications such as disease activity at de-escalation, disease prognostic features, and prior course of disease have been identified predominately in retrospective studies, allowing for risk stratification of patients. This review evaluates the published literature regarding therapeutic de-escalation and provides a framework for physicians to apply this to clinical practice. Prospective trials are underway and planned, which should provide further insight into this treatment paradigm and better inform patient selection for this strategy.


Assuntos
Colite Ulcerativa , Doença de Crohn , Doenças Inflamatórias Intestinais , Terapia Biológica , Humanos , Fatores Imunológicos , Estudos Prospectivos , Estudos Retrospectivos
10.
Scand J Gastroenterol ; 55(7): 795-799, 2020 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-32584190

RESUMO

Objectives: We performed a pathological pilot study to characterize the inflammation at the ileocolic anastomosis as Crohn's disease or ischemia.Methods and materials: Subjects were selected at random from a retrospective database of patients with Crohn's disease and who had undergone an ileocolic resection with subsequent endoscopic assessment of the anastomosis and neo-terminal ileum. Pathology slides from the anastomotic mucosa, either from targeted biopsies or subsequent ileocolic resections, were re-assessed histologically for features of ischemia and of Crohn's disease.Results: Twenty-nine specimens from 8 patients were reviewed, including 12 ileocolic resection specimens and 17 sets of endoscopic biopsies. Twenty-seven of the 29 specimens, accounting for all of the patients, had evidence of CD-like features. In contrast, only 2 specimens, accounting for 2 of 8 patients, had histologic features of ischemia, and both specimens also had Crohn's-like features.Conclusion: To our knowledge this is the first study to specifically evaluate the pathology of ileocolic anastomoses in Crohn's disease. It suggests that anastomotic inflammation is predominantly a manifestation of recurrent Crohn's disease rather than of postoperative ischemia.


Assuntos
Anastomose Cirúrgica/efeitos adversos , Colectomia/efeitos adversos , Doença de Crohn/patologia , Doença de Crohn/cirurgia , Adulto , Colo/cirurgia , Feminino , Humanos , Íleo/cirurgia , Inflamação/etiologia , Masculino , Projetos Piloto , Complicações Pós-Operatórias/etiologia , Recidiva , Estudos Retrospectivos , Adulto Jovem
11.
Clin Gastroenterol Hepatol ; 16(9): 1374-1384, 2018 09.
Artigo em Inglês | MEDLINE | ID: mdl-29481970

RESUMO

Current therapies used in the treatment of inflammatory bowel disease (IBD) are not effective in all patients. Biologic agents result in approximately 40% remission rates at 1 year in selected populations, prompting a growing interest in combining biologic therapy to improve outcomes. There are limited published data regarding the efficacy and safety of combination targeted therapy in IBD specifically, which include only 1 exploratory randomized control trial and 3 case reports or series. This review evaluates the published literature regarding this therapeutic paradigm in IBD and its extensive utilization in the treatment of other immune-mediated inflammatory disorders. The combination of biologic therapies demonstrates variable degrees of efficacy and highlights some safety concerns, depending upon the agents used and the disease state treated. A trial (Clinical Trials.gov Identifier: NCT02764762) combining vedolizumab and adalimumab is currently underway evaluating the effectiveness and safety of this approach in patients with Crohn's disease, which should provide further insight into this treatment concept. While combination biologic therapy is an attractive strategy, the lack of consistent superior efficacy as well as safety concerns militates the need for further trials prior to its general application in IBD.


Assuntos
Artrite Reumatoide/tratamento farmacológico , Produtos Biológicos/uso terapêutico , Quimioterapia Combinada/métodos , Fatores Imunológicos/uso terapêutico , Doenças Inflamatórias Intestinais/tratamento farmacológico , Psoríase/tratamento farmacológico , Esclerite/tratamento farmacológico , Anti-Inflamatórios/efeitos adversos , Anti-Inflamatórios/uso terapêutico , Produtos Biológicos/efeitos adversos , Quimioterapia Combinada/efeitos adversos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Humanos , Fatores Imunológicos/efeitos adversos , Resultado do Tratamento
12.
Clin Gastroenterol Hepatol ; 19(6): 1301-1302, 2021 06.
Artigo em Inglês | MEDLINE | ID: mdl-33248096
14.
Sci Rep ; 14(1): 2833, 2024 02 03.
Artigo em Inglês | MEDLINE | ID: mdl-38310197

RESUMO

Wearable devices can non-invasively monitor patients with chronic diseases. Sweat is an easily accessible biofluid for continuous sampling of analytes, including inflammatory markers and cytokines. We evaluated a sweat sensing wearable device in subjects with and without inflammatory bowel disease (IBD), a chronic inflammatory condition of the gastrointestinal tract. Participants with an IBD related hospital admission and a C-reactive protein level above 5 mg/L wore a sweat sensing wearable device for up to 5 days. Tumor necrosis factor-alpha (TNF-α) levels were continually assessed in the sweat via the sensor, and daily in the blood. A second cohort of healthy subjects without chronic diseases wore the device for up to 48 h. Twenty-eight subjects were enrolled. In the 16 subjects with IBD, a moderate linear relationship between serum and sweat TNF-α levels was observed (R2 = 0.72). Subjects with IBD were found to have a mean sweat TNF-α level of 2.11 pg/mL, compared to a mean value of 0.19 pg/mL in 12 healthy controls (p < 0.0001). Sweat TNF-α measurements differentiated subjects with active IBD from healthy subjects with an AUC of 0.962 (95% CI 0.894-1.000). A sweat sensing wearable device can longitudinally measure key sweat-based markers of IBD. TNF-α levels in the sweat of subjects with IBD correlate with serum values, suggesting feasibility in non-invasive disease monitoring.


Assuntos
Doenças Inflamatórias Intestinais , Dispositivos Eletrônicos Vestíveis , Humanos , Fator de Necrose Tumoral alfa , Suor , Doenças Inflamatórias Intestinais/diagnóstico , Doença Crônica
15.
Artigo em Inglês | MEDLINE | ID: mdl-38317723

RESUMO

There are limitations to monitoring modalities for chronic inflammatory conditions, including inflammatory bowel disease (IBD). Wearable devices are scalable mobile health technology that present an opportunity to monitor markers that have been linked to worsening, chronic inflammatory conditions and enable remote monitoring. In this research article, we evaluate and demonstrate a proof-of-concept wearable device to longitudinally monitor inflammatory and immune markers linked to IBD disease activity in sweat compared to expression in serum. Sixteen participants with an IBD-related hospital admission and a C-reactive protein (CRP) > 5 µg/mL were followed for up to 5 days. The sweat sensing device also known as IBD AWARE was worn to continuously measure CRP and interleukin-6 (IL-6) in the sweat of participants via electrochemical impedance spectroscopy. Serum samples were collected daily. A linear relationship between serum and sweat readings for CRP and IL-6 was demonstrated based on individual linear correlation coefficients. Pooled CRP and IL-6 serum-to-sweat ratios demonstrated improving correlation coefficients as serum cutoffs decreased. Between the first and last day of observation, significant and non-significant trends in serum CRP and IL-6 were observed in the sweat. Comparison of sweat measurements between the subjects with active IBD and 10 healthy subjects distinguished an inflamed and uninflamed state with an AUC of 0.85 (95% CI: 0.68-1.00) and a sensitivity and specificity of 82% and 70% at a CRP cutoff of 938.9 pg/mL. IBD AWARE wearable device holds promise in longitudinally monitoring individuals with IBD and other inflammatory diseases.

16.
JMIR Ment Health ; 11: e55552, 2024 Apr 25.
Artigo em Inglês | MEDLINE | ID: mdl-38663011

RESUMO

BACKGROUND: Heart rate variability (HRV) biofeedback is often performed with structured education, laboratory-based assessments, and practice sessions. It has been shown to improve psychological and physiological function across populations. However, a means to remotely use and monitor this approach would allow for wider use of this technique. Advancements in wearable and digital technology present an opportunity for the widespread application of this approach. OBJECTIVE: The primary aim of the study was to determine the feasibility of fully remote, self-administered short sessions of HRV-directed biofeedback in a diverse population of health care workers (HCWs). The secondary aim was to determine whether a fully remote, HRV-directed biofeedback intervention significantly alters longitudinal HRV over the intervention period, as monitored by wearable devices. The tertiary aim was to estimate the impact of this intervention on metrics of psychological well-being. METHODS: To determine whether remotely implemented short sessions of HRV biofeedback can improve autonomic metrics and psychological well-being, we enrolled HCWs across 7 hospitals in New York City in the United States. They downloaded our study app, watched brief educational videos about HRV biofeedback, and used a well-studied HRV biofeedback program remotely through their smartphone. HRV biofeedback sessions were used for 5 minutes per day for 5 weeks. HCWs were then followed for 12 weeks after the intervention period. Psychological measures were obtained over the study period, and they wore an Apple Watch for at least 7 weeks to monitor the circadian features of HRV. RESULTS: In total, 127 HCWs were enrolled in the study. Overall, only 21 (16.5%) were at least 50% compliant with the HRV biofeedback intervention, representing a small portion of the total sample. This demonstrates that this study design does not feasibly result in adequate rates of compliance with the intervention. Numerical improvement in psychological metrics was observed over the 17-week study period, although it did not reach statistical significance (all P>.05). Using a mixed effect cosinor model, the mean midline-estimating statistic of rhythm (MESOR) of the circadian pattern of the SD of the interbeat interval of normal sinus beats (SDNN), an HRV metric, was observed to increase over the first 4 weeks of the biofeedback intervention in HCWs who were at least 50% compliant. CONCLUSIONS: In conclusion, we found that using brief remote HRV biofeedback sessions and monitoring its physiological effect using wearable devices, in the manner that the study was conducted, was not feasible. This is considering the low compliance rates with the study intervention. We found that remote short sessions of HRV biofeedback demonstrate potential promise in improving autonomic nervous function and warrant further study. Wearable devices can monitor the physiological effects of psychological interventions.


Assuntos
Biorretroalimentação Psicológica , Frequência Cardíaca , Dispositivos Eletrônicos Vestíveis , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Biorretroalimentação Psicológica/métodos , Biorretroalimentação Psicológica/instrumentação , Pessoal de Saúde , Frequência Cardíaca/fisiologia , Cidade de Nova Iorque , Estudos Prospectivos , Telemedicina/métodos , Telemedicina/instrumentação
17.
JMIR Res Protoc ; 12: e49204, 2023 Nov 16.
Artigo em Inglês | MEDLINE | ID: mdl-37971801

RESUMO

BACKGROUND: The increasing use of smartphones, wearables, and connected devices has enabled the increasing application of digital technologies for research. Remote digital study platforms comprise a patient-interfacing digital application that enables multimodal data collection from a mobile app and connected sources. They offer an opportunity to recruit at scale, acquire data longitudinally at a high frequency, and engage study participants at any time of the day in any place. Few published descriptions of centralized digital research platforms provide a framework for their development. OBJECTIVE: This study aims to serve as a road map for those seeking to develop a centralized digital research platform. We describe the technical and functional aspects of the ehive app, the centralized digital research platform of the Hasso Plattner Institute for Digital Health at Mount Sinai Hospital, New York, New York. We then provide information about ongoing studies hosted on ehive, including usership statistics and data infrastructure. Finally, we discuss our experience with ehive in the broader context of the current landscape of digital health research platforms. METHODS: The ehive app is a multifaceted and patient-facing central digital research platform that permits the collection of e-consent for digital health studies. An overview of its development, its e-consent process, and the tools it uses for participant recruitment and retention are provided. Data integration with the platform and the infrastructure supporting its operations are discussed; furthermore, a description of its participant- and researcher-facing dashboard interfaces and the e-consent architecture is provided. RESULTS: The ehive platform was launched in 2020 and has successfully hosted 8 studies, namely 6 observational studies and 2 clinical trials. Approximately 1484 participants downloaded the app across 36 states in the United States. The use of recruitment methods such as bulk messaging through the EPIC electronic health records and standard email portals enables broad recruitment. Light-touch engagement methods, used in an automated fashion through the platform, maintain high degrees of engagement and retention. The ehive platform demonstrates the successful deployment of a central digital research platform that can be modified across study designs. CONCLUSIONS: Centralized digital research platforms such as ehive provide a novel tool that allows investigators to expand their research beyond their institution, engage in large-scale longitudinal studies, and combine multimodal data streams. The ehive platform serves as a model for groups seeking to develop similar digital health research programs. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/49204.

18.
JAMIA Open ; 6(2): ooad029, 2023 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-37143859

RESUMO

Objective: To assess whether an individual's degree of psychological resilience can be determined from physiological metrics passively collected from a wearable device. Materials and Methods: Data were analyzed in this secondary analysis of the Warrior Watch Study dataset, a prospective cohort of healthcare workers enrolled across 7 hospitals in New York City. Subjects wore an Apple Watch for the duration of their participation. Surveys were collected measuring resilience, optimism, and emotional support at baseline. Results: We evaluated data from 329 subjects (mean age 37.4 years, 37.1% male). Across all testing sets, gradient-boosting machines (GBM) and extreme gradient-boosting models performed best for high- versus low-resilience prediction, stratified on a median Connor-Davidson Resilience Scale-2 score of 6 (interquartile range = 5-7), with an AUC of 0.60. When predicting resilience as a continuous variable, multivariate linear models had a correlation of 0.24 (P = .029) and RMSE of 1.37 in the testing data. A positive psychological construct, comprised of resilience, optimism, and emotional support was also evaluated. The oblique random forest method performed best in estimating high- versus low-composite scores stratified on a median of 32.5, with an AUC of 0.65, a sensitivity of 0.60, and a specificity of 0.70. Discussion: In a post hoc analysis, machine learning models applied to physiological metrics collected from wearable devices had some predictive ability in identifying resilience states and a positive psychological construct. Conclusions: These findings support the further assessment of psychological characteristics from passively collected wearable data in dedicated studies.

19.
JAMIA Open ; 5(2): ooac041, 2022 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-35677186

RESUMO

Objective: To determine whether a machine learning model can detect SARS-CoV-2 infection from physiological metrics collected from wearable devices. Materials and Methods: Health care workers from 7 hospitals were enrolled and prospectively followed in a multicenter observational study. Subjects downloaded a custom smart phone app and wore Apple Watches for the duration of the study period. Daily surveys related to symptoms and the diagnosis of Coronavirus Disease 2019 were answered in the app. Results: We enrolled 407 participants with 49 (12%) having a positive nasal SARS-CoV-2 polymerase chain reaction test during follow-up. We examined 5 machine-learning approaches and found that gradient-boosting machines (GBM) had the most favorable validation performance. Across all testing sets, our GBM model predicted SARS-CoV-2 infection with an average area under the receiver operating characteristic (auROC) = 86.4% (confidence interval [CI] 84-89%). The model was calibrated to value sensitivity over specificity, achieving an average sensitivity of 82% (CI ±âˆ¼4%) and specificity of 77% (CI ±âˆ¼1%). The most important predictors included parameters describing the circadian heart rate variability mean (MESOR) and peak-timing (acrophase), and age. Discussion: We show that a tree-based ML algorithm applied to physiological metrics passively collected from a wearable device can identify and predict SARS-CoV-2 infection. Conclusion: Applying machine learning models to the passively collected physiological metrics from wearable devices may improve SARS-CoV-2 screening methods and infection tracking.

20.
Therap Adv Gastroenterol ; 15: 17562848221132363, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36348637

RESUMO

Background: Inflammatory bowel disease (IBD) is not associated with worse coronavirus disease 2019 (COVID-19) outcomes. However, data are lacking regarding the long-term impact of severe acute respiratory syndrome coronavirus 2 infection on the disease course of IBD. Objectives: We aimed to investigate the effect of COVID-19 on long-term outcomes of IBD. Design: We performed a multicenter case-control study of patients with IBD and COVID-19 between February 2020 and December 2020. Methods: Cases and controls were individuals with IBD with presence or absence, respectively, of COVID-19-related symptoms and confirmatory testing. The primary composite outcome was IBD-related hospitalization or surgery. Results: We identified 251 cases [ulcerative colitis (n = 111, 45%), Crohn's disease (n = 139, 55%)] and 251 controls, with a median follow-up of 394 days. The primary composite outcome of IBD-related hospitalization or surgery occurred in 29 (12%) cases versus 38 (15%) controls (p = 0.24) and on multivariate Cox regression, COVID-19 was not associated with increased risk of adverse IBD outcomes [adjusted hazard ratio (aHR): 0.84, 95% confidence interval [CI]: 0.44-1.42]. When stratified by infection severity, severe COVID-19 was associated with a numerically increased risk of adverse IBD outcomes (aHR: 2.43, 95% CI: 1.00-5.86), whereas mild-to-moderate COVID-19 was not (aHR: 0.68, 95% CI: 0.38-1.23). Conclusion: In this case-control study, COVID-19 did not have a long-term impact on the disease course of IBD. However, severe COVID-19 was numerically associated with worse IBD outcomes, underscoring the continued importance of risk mitigation and prevention strategies for patients with IBD during the ongoing COVID-19 pandemic.

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